Selecting a Notified Body (NB) is an important (and required) step for obtaining CE Marking and registering your medical device for sale in the European Union. Your NB audits your quality management system and review your Technical File to ensure it complies with the appropriate EU Directive.
There are many accredited Notified Bodies in Europe - but some may be better suited to partner with your company than others. This article discusses key points of the Notified Body search, including how to find a new Notified Body partner. You will learn:
- What is the difference between a Notified Body and a Registrar?
- What should we consider during our search?
- What should we consider when reviewing proposals from Notified Bodies?
- What are reasons we might need to switch Notified Bodies?
- What are the logistics of switching Notified Bodies?
We answer all these questions and more in this 5-page white paper.